Validation of the Smart Mask V1 System and Its Measurements of SpO2 and Pulse Rate

Validation of the Smart Mask V1 System and Its Measurements of SpO2 and Pulse Rate

The goal of this clinical study is to investigate a new medical device, the Smart Mask V1 System (herein 'Smart Mask'), and particularly its measurements of blood oxygen levels (SpO2) and pulse rate (PR) in healthy adults aged 18 to 65.

More specifically, the study is directed at answering the following questions:

• Can the Smart Mask accurately measure SpO2 levels compared to established reference devices (reference oximeters, blood gas) throughout the range of SpO2 ~ 70 - 100%?
• Can the Smart Mask accurately measure PR during the same conditions?
• Does skin pigmentation impact the accuracy of Smart Mask's measurements of SpO2 and PR.

The following reference devices will be used in the study:

• An FDA-cleared fingertip pulse oximeter (Nellcor Portable SpO2 Patient Monitoring System, PM10N)
• A laboratory-grade CO-oximeter (Radiometer ABL90 FLEX) that analyzes oxygen saturation from blood samples.

Study participants will:

• Wear the Smart Mask on their face and a fingertip pulse oximeter while lying down
• Breathe air with gradually reduced oxygen levels inside a specialized hypoxia room while being closely.
• In a second phase of the study, have a catheter inserted into a wrist artery for blood sampling to directly measure oxygen levels with the CO-oximeter.

This clinical study evaluates the Smart Mask V1 System, a medical device designed to measure blood oxygen saturation (SpO2) and pulse rate (PR) using reflective photoplethysmography (PPG) sensors integrated into a face mask intended for use with positive airway pressure (PAP) therapy. The study aims to validate the accuracy of the Smart Mask's optical measurements under controlled, progressive hypoxia conditions in healthy adult volunteers.

The investigation is divided into two sequential phases; Non-Invasive (NI) and Invasive (IN) Study. All study sessions are conducted at the Complementary Medical Centre (CMC) in Genk, Belgium, within a certified normobaric hypoxia room. This room is sealed and climate-controlled, equipped with oxygen and carbon dioxide sensors to maintain a stable and safe hypoxic environment.

Hypoxia is induced gradually to reduce any discomfort or potential risk to participants. Comprehensive safety protocols are in place to protect volunteers. These include medical screening and obtaining informed consent prior to enrollment, as well as real-time monitoring by trained medical staff throughout the exposure. Immediate exit protocols are activated if a participant's SpO2 falls below 73% or if symptoms of acute mountain sickness are observed. Emergency oxygen and resuscitation equipment are readily available on-site. Additionally, participants are reminded that they may withdraw from the study at any time without penalty.

Inclusion Criteria:

• Healthy subjects with ASA health score of I or II
• Subjects aged between ≥ 18 and ≤ 65 years.
• Subjects who have provided informed consent and are willing to comply with the study procedures.

Exclusion Criteria:

• Heavy smokers or individuals exposed to high levels of carbon monoxide resulting in elevated carboxyhemoglobin levels.
• Individuals with conditions that result in elevated methemoglobin levels.
• Individuals with hypoxia (SpO2 < 95% at 21% O2).
• Severe claustrophobia.
• Subjects known with altitude sickness.
• Subjects who are obese (BMI ≥ 35 kg/m2).
• Subjects with a known history of moderate to severe heart, lung, kidney or liver disease.
• Subjects diagnosed with moderate to severe asthma.
• Subjects with a hemoglobinopathy or history of anemia, e.g. sickle cell anemia, thalassemia, that in the investigator's opinion, would make them unsuitable for study participation.
• Subjects with any other serious systemic illness.
• Any injury, deformity, or abnormality at the sensor sites that, in the investigator's opinion, would interfere with the correct functioning of the test or reference devices.
• Subjects with a history of fainting or vasovagal response.
• Subjects with a history of sensitivity or allergy to local anesthetics or disinfectants if included in the IN study.
• Subjects diagnosed with Raynaud's disease.
• Subjects with unacceptable collateral circulation based on examination by the investigator.
• Subjects who are pregnant, lactating or trying to become pregnant.
• Subjects unable or unwilling to provide informed consent or comply with study procedures.
• Subjects with any other condition that, in the investigator's opinion, would make them unsuitable for the study.
• Subjects who refuse to remove nail polish from their index finger.
• Volunteers not willing to remove facial make-up.